NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions

NCT01703000 | Completed Results

• 1 other identifier: NG PROMUS Clinical Trial S2294
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 9

Brief Summary

NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of Atherosclerotic Lesion(s)

Conditions

Atherosclerosis; Coronary Artery Disease

Keywords

drug eluting coronary stent

Outcome Measures

Primary Outcomes (1)

• Technical Success Rate

  Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician

  Participants will be followed for the duration of hospital stay, an expected average of 1 day

Secondary Outcomes (27)

• Target Lesion Revascularization (TLR) Rate

  Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

• Target Lesion Failure (TLF) Rate

  Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

• Target Vessel Revascularization (TVR) Rate

  Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

• Target Vessel Failure (TVF) Rate

  Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

• Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate

  Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days

Study Arms (1)

NG PROMUS stent

EXPERIMENTAL

Single-arm treatment group receiving interventional NG PROMUS study stent

Device: Percutaneous coronary intervention (NG PROMUS)

Interventions

Percutaneous coronary intervention (NG PROMUS) DEVICE

Interventional coronary artery stenting with NG PROMUS study stent.

NG PROMUS stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 18 years of age
• Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
• Subject is eligible for percutaneous coronary intervention (PCI)
• Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
• Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
• Subject is willing to comply with all protocol-required follow-up evaluation
• Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.50 mm and ≤4.0 mm
• Target lesion(s) length must be ≤34 mm (by visual estimate)
• Target lesion(s) must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1 and one of the following (stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress test or imaging stress test, or elevated biomarkers) prior to procedure
• Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
• The first lesion treated must be successfully pre-dilated/pretreated Note: Successful pre-dilatation/pretreatment refers to dilatation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.

You may not qualify if:

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
• Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
• Subject has received an organ transplant or is on a waiting list for an organ transplant
• Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• Planned PCI (including staged procedures) or CABG after the index procedure
• Subject previously treated at any time with intravascular brachytherapy
• Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
• Subject has one of the following (as assessed prior to the index procedure):Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months; Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.);Planned procedure that may cause non-compliance with the protocol or confound data interpretation
• Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
• Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
• Subject has a white blood cell (WBC) count \< 3,000 cells/mm3
• Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
• Subject is on dialysis or has baseline serum creatinine level \>2.0 mg/dL (177µmol/L)
• Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (9)

Fremantle Hospital

Fremantle, Western Australia, 6160, Australia

Location

Mercy Angiography Unit, Ltd. Mercy Hospital

Auckland, 1003, New Zealand

Location

Auckland City Hospital

Auckland, 1010, New Zealand

Location

North Shore Hospital

Auckland, 1030, New Zealand

Location

Ascot Angiography

Auckland, 1546, New Zealand

Location

Christchurch

Christchurch, 8140, New Zealand

Location

Middlemore Hospital

Otahuhu, 1640, New Zealand

Location

National University Hospital Singapore

Singapore, 119228, Singapore

Location

National Heart Center Singapore

Singapore, 168752, Singapore

Location

Related Links

• Drug-eluting product information from Manufacturer

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Peter Maurer, Director Clinical Trials
• Organization: Boston Scientific

Peter.Maurer@bsci.com

508-683-6678

Study Officials

• John A Ormiston, MBChB, FRACP, FRACR

  Mercy Angiography Unit, Ltd. Mercy Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 15, 2014
• Results First Posted: March 21, 2014

Record last verified: 2014-03

Locations

AU (1); SG (2); NZ (6)